Vitamin B2 (Riboflavin)
City: LV, Marupe
Please avoid sudden changes in temperature and humidity, as they may affect the condition of derivative ingredients and tablets.
The shelf life begins from the date of manufacture at the factory.
Taking into account logistical and transportation stages, the remaining shelf life of the product is always shorter than the full shelf life.
We ship products to our customers with a remaining shelf life of no less than 70%.
Physical & Chemical Characteristics
Analysis Item | Specification | Result |
Appearance | Yellow or Orange-yellow, Crystalline powder | Complies |
Identification (Ph.Eur. Meth.A–C; USP; JP) | Must conform | Complies |
Specific optical rotation (Ph.Eur.) | -115 to -135° | -128 |
Specific optical rotation (USP) | -115 to -135° | -120 |
Specific optical rotation (FCC) | +56.5 to +59.5° | Complies |
Absorbance (Ph.Eur.) | 223,267,373,444 nm | Complies |
Maxima A 373/267 nm | 0.31 to 0.33 | 0.32 |
Maxima A 444/267 nm | 0.36 to 0.39 | 0.38 |
Impurity A | ≤0.025 g/100g | 0.008 |
Impurity B | ≤0.2 g/100g | 0.04 |
Impurity C | ≤0.2 g/100g | 0.0 |
Impurity D | ≤0.2 g/100g | 0.1 |
Unspecified impurities | ≤0.10 g/100g each | 0.00 |
Total Impurities | ≤0.5 g/100g | 0.1 |
Lumiflavin (USP) | ≤0.025 | 0.005 |
Lumiflavin (JECFA) | ≤0.025 g/100g | 0.008 |
Sulfated ash (Ph.Eur.) | ≤0.1% | 0.03% |
Residue on ignition (USP) | ≤0.3% | 0.03% |
Loss on drying (Ph.Eur.) | ≤1.5% | 0.9% |
Assay (Ph.Eur.) | 97.0–103.0 g/100g | 99.9% |
Assay (USP) | 98.0–102.0 g/100g | 99.3% |
Assay (JECFA) | 98.0–101.0 g/100g | 99.9% |
Particle size <50µm (SOP-0855) | ≥99 g/100g | Complies |
Heavy Metals
Analysis Item | Specification | Result |
Heavy Metals (USP) | ≤10 mg/kg | Complies |
Lead (KP ICP) | ≤1 mg/kg | Complies |
Cadmium (KP ICP) | ≤1 mg/kg | Complies |
Mercury (KP ICP) | ≤0.1 mg/kg | Complies |
Arsenic (KP ICP) | ≤1 mg/kg | Complies |
Microbiological Tests
Analysis Item | Specification | Result |
Total microbial aerobic count (USP) | ≤1000 CFU/g | Complies |
Total combined yeast and mold (USP) | ≤100 CFU/g | Complies |
Enterobacteria and other gram-negative (USP) | ≤100 CFU/g | Complies |
Escherichia coli (Ph.Eur.) | Negative | Negative |
Salmonella (Ph.Eur.) | Negative | Negative |
Staphylococcus aureus (Ph.Eur.) | Negative | Negative |
Pseudomonas aeruginosa (Ph.Eur.) | Negative | Negative |
Conclusion: The product meets the requirements of the current USP/EP/FCC/JP/E101/JECFA monograph